RECRUITING

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

Official Title

A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

Quick Facts

Study Start:2024-07-18
Study Completion:2027-05-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06527404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years)
  2. * Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.
  3. * Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to day 1.
  4. * Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk.
  5. * History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
  1. * Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed).
  2. * Prurigo nodularis secondary to medications.
  3. * Prurigo nodularis secondary to neurologic or psychiatric medical conditions.
  4. * Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization.
  5. * Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

First OC Dermatology
Fountain Valley, California, 92708
United States
Los Angeles Universal Research Center
Los Angeles, California, 90057
United States
Paradigm Clinical Research Center Inc
San Diego, California, 92108
United States
Wolverine Clinical Trials
Tustin, California, 92780
United States
Direct Helpers Research Center
Hialeah, Florida, 33012
United States
Wellness Clinical Research
Miami Lakes, Florida, 33016
United States
Southern Clinical Research
Miami, Florida, 33125
United States
University of Miami Hospital
Miami, Florida, 33125
United States
Miami Dermatology and Laser Institute
Miami, Florida, 33173
United States
Clinical Research Trials of Florida Inc
Tampa, Florida, 33607
United States
Olympian Clinical Research - Tampa
Tampa, Florida, 33615
United States
Emory University
Atlanta, Georgia, 30322
United States
NorthShore University HealthSystem
Skokie, Illinois, 60077
United States
The Indiana Clinical Trials Center PC
Plainfield, Indiana, 46168
United States
Revival Research Institute, LLC
Troy, Michigan, 48084
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10028
United States
Optima Research
Boardman, Ohio, 44512
United States
Wright State Physicians
Fairborn, Ohio, 45324
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102
United States
Center For Clinical Studies PLLC
Houston, Texas, 77004
United States
Clarity Dermatology
Lancaster, Texas, 75146
United States
Springville Dermatology
Springville, Utah, 84663
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-18
Study Completion Date2027-05-15

Study Record Updates

Study Start Date2024-07-18
Study Completion Date2027-05-15

Terms related to this study

Keywords Provided by Researchers

  • Rocatinlimab

Additional Relevant MeSH Terms

  • Prurigo Nodularis